CN104398483B - A kind of olmesartan medoxomil tablet and its preparation technology - Google Patents
A kind of olmesartan medoxomil tablet and its preparation technology Download PDFInfo
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- CN104398483B CN104398483B CN201410618016.9A CN201410618016A CN104398483B CN 104398483 B CN104398483 B CN 104398483B CN 201410618016 A CN201410618016 A CN 201410618016A CN 104398483 B CN104398483 B CN 104398483B
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Abstract
The present invention relates to a kind of olmesartan medoxomil tablet and its preparation technology, olmesartan medoxomil tablet label is made up of olmesartan medoxomil and pharmaceutic adjuvant direct tablet compressing, 1 100 microns of the particle diameter at the cumulative volume of olmesartan medoxomil 90%；The pharmaceutic adjuvant includes filler, disintegrant and lubricant, and wherein lubricant is from the one or more in neutral or inert lubricant.The weight part ratio of raw material is 20 parts of olmesartan medoxomil, 80 180 parts of filler, 10 20 parts of disintegrant, 2 10 parts of lubricant in label.Olmesartan medoxomil of the present invention is crushed using air-flow crushing mode, control particle diameter, preparation technology uses direct powder compression, avoid being introduced into of moisture content in wet-granulation process, in wet granular drying process Viability material degraded, the generation of hydrolysis is prevented, drug substance stable, stripping property are good, it is simple to prepare.
Description
Technical field
The present invention relates to a kind of olmesartan medoxomil tablet and its preparation technology, belong to field of medicine preparing technology.
Background technology
There are some reports on olmesartan medoxomil preparation technique in the prior art.Such as patent document CN101478966A
A kind of pharmaceutical preparation and its preparation method containing olmesartan medoxomil for the elution property for having and improving is disclosed, wherein except containing Austria
Outside Mei Shatan esters, also disintegrant, diluent, lubrication are selected from containing appropriate excipient and its assistant agent, the excipient and assistant agent
Agent, adhesive, emulsifying agent, flavor enhancement and suitable activating agent.The process employs the method for high pressure compressed, this method power consumption
It is big and high to the performance requirement of equipment.Patent document CN102119930A discloses a kind of olmesartan medoxomil tablet and its preparation side
Method, auxiliary material include lactose, microcrystalline cellulose, PVPK30, low-substituted hydroxypropyl cellulose, magnesium stearate and appropriate second
Alcohol-water, need in this preparation method to grind medicine and lactose so that complex process, poor controllability.Patent document
CN103040777A discloses a kind of olmesartan ester liposome solid preparation and its preparation method, by by olmesartan medoxomil with it is specific
Auxiliary material combination be prepared into liposome to improve the stability of medicine, this preparation method is extremely complex, and the production cycle is grown, raw
This height is produced, is unfavorable for industrialization.Patent document CN102028663A discloses a kind of olmesartan medoxomil solid preparation of stabilization
Preparation method, reduce the degraded of olmesartan medoxomil by way of adding PH conditioning agents and stabilizer, preparation method is using wet
Method is pelletized, although replacing water with absolute ethyl alcohol to prevent the hydrolysis of active component, has been used during this method grain organic molten
Agent, great potential safety hazard is brought to production process, Determination of Residual Organic Solvents is also required to strict control so that production cost
Height, work are powerful.
The content of the invention
The purpose of the present invention is to overcome above-mentioned deficiency, and provides a kind of olmesartan medoxomil tablet and its preparation technology, product matter
Amount is stable, and technique is simple, cost-effective.
The technical scheme that the present invention takes is：
A kind of olmesartan medoxomil tablet, label are made up of olmesartan medoxomil and pharmaceutic adjuvant direct tablet compressing, olmesartan medoxomil
Particle diameter 1-100 microns at 90% cumulative volume.
The olmesartan medoxomil tablet, pharmaceutic adjuvant include filler, disintegrant and lubricant, and wherein lubricant is from neutral
Or the one or more in inert lubricant.
The weight part ratio of above-mentioned label Central Plains material is 20 parts of olmesartan medoxomil, filler 80-180 parts, disintegrant 10-20
Part, lubricant 2-10 parts.
Preferably 1~60 micron of particle diameter at the described cumulative volume of olmesartan medoxomil 90%, most preferably 90% cumulative volume
The particle diameter at place is not more than 30 microns.
One kind in stearic acid, sodium stearyl fumarate, Compritol 888 ATO, rilanit special of described lubricant or
It is several；Most preferably Compritol 888 ATO.Filler is preferably the mixture of lactose and microcrystalline cellulose.
The weight part ratio composition of raw material is preferably 20 parts of olmesartan medoxomil, lactose 100-135 parts, low taken in described label
For hydroxypropyl cellulose 10-20 parts, microcrystalline cellulose 30-42 parts, Compritol 888 ATO 2-10 parts.
A kind of preparation technology of olmesartan medoxomil tablet, including step are as follows：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
Solve agent and lubricant；
(2) raw material crushes：Olmesartan medoxomil is crushed by air-flow crushing mode, controls the particle diameter at 90% cumulative volume
In 1-100 microns；
(3) mix：The olmesartan medoxomil of crushing is mixed with the filler in pharmaceutic adjuvant, disintegrant, is eventually adding profit
Lubrication prescription mixes；
(4) raw material after mixing, according to granule content tabletting；
(5) it is coated, coating weight gain 2-3%.
In above-mentioned preparation technology, the weight part ratio of raw material is 20 parts of olmesartan medoxomil, filler 80-180 parts, collapsed in label
Solve agent 10-20 parts, lubricant 5-10 parts.
Described filler is selected from mannitol, sorbierite, dextrin, cyclodextrin and its derivative, sucrose, calcium phosphate, crystallite
One kind in cellulose, starch, pregelatinized starch, calcium sulfate, calcium monohydrogen phosphate, xylitol, fructose, maltitol, dextran
Or several, the preferably mixture of lactose and microcrystalline cellulose, lactose preferably spray drying type, the preferred PH102 of microcrystalline cellulose
Type.
Described disintegrant is selected from cellulose derivative such as low-substituted hydroxypropyl cellulose, sodium carboxymethylcellulose, carboxylic first
Base cellulose calcium, cross-linked carboxymethyl cellulose sodium, PVPP, modified starch/modified cellulose such as pregelatinized starch, carboxymethyl
One or more in sodium starch, CMS, crosslinked carboxymethyl fecula sodium, disintegrant of the present invention are preferably low take
For hydroxypropyl cellulose LH11 types.
Described lubricant be selected from stearic acid, Metallic stearates, talcum powder, colloidal silicon, wax class, Compritol 888 ATO,
One or more in rilanit special boric acid, aliphatic acid, bisulfate, lauryl sulfate, silicate, it is preferably stearic
One or more in acid, sodium stearyl fumarate, Compritol 888 ATO, rilanit special；Most preferably Compritol 888 ATO.
Particle diameter of the above-mentioned olmesartan medoxomil particle diameter preferably at 90% cumulative volume is not more than 45 microns, and most preferably 90% is tired
Count the particle diameter at volume and be not more than 30 microns.
For the olmesartan medoxomil tablet using neutral or inert lubricant, its preparation technology can be：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
It is neutral lubricant or inert lubricant to solve agent and lubricant, lubricant；
(2) mix：Olmesartan medoxomil is mixed with the filler in pharmaceutic adjuvant, disintegrant, lubricant is eventually adding and mixes
Close；
(3) raw material after mixing, according to granule content tabletting；
(4) it is coated.
Neutral lubricant or inert lubricant are selected in stearic acid, sodium stearyl fumarate, Compritol 888 ATO, rilanit special
One or more；Most preferably Compritol 888 ATO.
Film coating matrix is for example in coating：Sweet tablet matrix, water-soluble film coated substrate, intestines film coating matrix and
The film coating matrix of sustained release.
For " sweet tablet matrix ", using sucrose, it can be with one or more selected from talcum, winnofil, phosphorus
Sour calcium, calcium sulfate, gel, gum arabic, the additive of polyvinylpyrrolidone are applied in combination.
For " water-soluble film coated substrate ", it can be mentioned that cellulose derivative, such as hydroxypropyl cellulose, hydroxypropyl
Ylmethyl cellulose, hydroxyethyl cellulose, methyl hydroxyethylcellulose and sodium carboxymethylcellulose；Synthetic polymer, such as two
Ethylamino polyvinyl acetate alcohol acetal ester, EDURAGIT E 100 and polyvinylpyrrolidone；Polysaccharide, example
Such as amylopectin.
For " intestines film coating matrix ", it can be mentioned that cellulose derivative, such as phthalic acid hydroxypropyl methyl
Cellulose, acetic acid butanedioic acid hydroxypropyl methyl cellulose, carboxymethylethylcellulose and cellulose acetate phthalate；Propylene
Acid derivative, such as Eudragit L100, Eudragit L100D55, Eudragit S100；Natural drug,
Such as lac.
For " the film coating matrix of sustained release ", it can be mentioned that cellulose derivative, such as ethyl cellulose；Third
Gadoleic acid derivative, such as methacrylic acid amino ester copolymer RS, EUDRAGIT NE 30 D breast
Liquid.
Coating can also contain the appropriate acceptable additive of pharmacology with two or more different coated substrates,
Such as plasticizer, excipient, lubricant, opacifiers, colouring agent or preservative.Film-coating material of the present invention is preferably water
Soluble film's coating agent.
The beneficial effects of the invention are as follows：
(1) selection of lubricant
Alkaline lubricants can cause the degraded of bulk drug, and generally signified alkaline lubricants include magnesium stearate, stearic acid
Calcium, zinc stearate etc., the present invention from neutral or inert lubricant, as stearic acid, sodium stearyl fumarate, Compritol 888 ATO,
One or more of compositions of rilanit special etc., preferably Compritol 888 ATO, enhance medicine stability.
(2) selection of particle diameter
Dissolution of the particle diameter to medicine has considerable influence, and the particle diameter stripping property that the present invention selects is good, when olmesartan medoxomil 90%
Particle diameter at cumulative volume is D90=1~60 micron, and preferably the particle diameter at 90% cumulative volume is not more than 45 microns, most preferably
Particle diameter at 90% cumulative volume is not more than 30 microns.
(3) effect of powder vertical compression
Olmesartan medoxomil belongs to ester type compound, such compound can occur with water hydrolysis generation it is corresponding sour and
Alcohol, impurity increase, and influence drug quality, therefore use direct powder compression, avoid the introducing of moisture content in wet-granulation process,
The degraded of Viability material in wet granular drying process, prevents the generation of hydrolysis.
(4) technical process
Reduce equipment and the cost of running, its simple production process, without pelletizing, sieving, drying, the process such as whole grain,
Cost and labor intensity are reduced, saves time and the energy, and do not make final products matter because the experience of worker determines the quality of product
Amount is stable, and difference is small between batch, and workable, continuous production is guaranteed.
The technology barrier for restricting powder vertical compression piece is mainly fluidics property (such as compressibility, mobility of supplementary material itself
And content uniformity etc.), the present invention by auxiliary material it is preferred, combination (such as lactose preferably spray drying type, microcrystalline cellulose are excellent
Select PH102 types, the preferred LH11 types of low-substituted hydroxypropyl cellulose) and olmesartan medoxomil particle diameter control, ensure that supplementary material mix
Compressibility, mobility and the content uniformity of gained powder afterwards, is adapted to industrialized production.
Embodiment
Further illustrated with reference to preferred embodiment.
Embodiment 1
A kind of preparation technology of olmesartan medoxomil tablet, including step are as follows：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
Solve agent and lubricant, the weight part ratio composition of raw material is shown in Table 1 in label；
(2) raw material crushes：Olmesartan medoxomil is crushed by air-flow crushing mode, controls the particle diameter at 90% cumulative volume
In 1-100 microns；
(3) mix：The olmesartan medoxomil of crushing is mixed with the filler in pharmaceutic adjuvant, disintegrant, is eventually adding profit
Lubrication prescription mixes；
(4) raw material after mixing, according to granule content tabletting；
(5) it is coated.
Embodiment 2
A kind of preparation technology of olmesartan medoxomil tablet, step is with embodiment 1, and the weight part ratio composition of raw material is shown in Table in label
1。
Embodiment 3
A kind of preparation technology of olmesartan medoxomil tablet, including step are as follows：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
Solve agent and lubricant, the weight part ratio composition of raw material is shown in Table 1 in label；
(2) raw material crushes：Olmesartan medoxomil is crushed by air-flow crushing mode, controls the particle diameter at 90% cumulative volume
Less than 30 microns；
(3) mix：The olmesartan medoxomil of crushing is first mixed with lactose, it is fine to add microcrystalline cellulose, low-substituted hydroxypropyl
Dimension element mixing, is eventually adding mix lubricant；
(4) raw material after mixing, according to granule content tabletting；
(5) it is coated.
Embodiment 4
A kind of preparation technology of olmesartan medoxomil tablet, step is with embodiment 3, and the weight part ratio composition of raw material is shown in Table in label
1。
Embodiment 5
A kind of preparation technology of olmesartan medoxomil tablet, including step are as follows：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
Solve agent and lubricant, the weight part ratio composition of raw material is shown in Table 2 in label；
(2) raw material crushes：Olmesartan medoxomil is crushed by air-flow crushing mode, controls the particle diameter at 90% cumulative volume
30~100 microns；
(3) mix：The olmesartan medoxomil of crushing is mixed with the filler in pharmaceutic adjuvant, disintegrant, is eventually adding profit
Lubrication prescription mixes；
(4) raw material after mixing, according to granule content tabletting；
(5) it is coated.
Embodiment 6
A kind of preparation technology of olmesartan medoxomil tablet, including step are as follows：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
Solve agent and lubricant, the weight part ratio composition of raw material is shown in Table 2 in label；
(2) raw material crushes：Olmesartan medoxomil is crushed by air-flow crushing mode, controls the particle diameter at 90% cumulative volume
More than 100 microns；
(3) mix：The olmesartan medoxomil of crushing is mixed with the filler in pharmaceutic adjuvant, disintegrant, is eventually adding profit
Lubrication prescription mixes；
(4) raw material after mixing, according to granule content tabletting；
(5) it is coated.
Embodiment 7
A kind of preparation technology of olmesartan medoxomil tablet, including step are as follows：
(1) piece core raw material is chosen：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, collapsed
It is neutral lubricant Compritol 888 ATO to solve agent and lubricant, lubricant；
(2) mix：Olmesartan medoxomil is mixed with the filler in pharmaceutic adjuvant, disintegrant, lubricant is eventually adding and mixes
Close；
(3) raw material after mixing, according to granule content tabletting；
(4) it is coated.
Table 1
Table 2
Performance test
1. the outward appearance of each embodiment product is contrasted, it is as a result as follows：
The selection result of table 3
2. stability test and dissolution results
(1) Acceleration study result
Embodiment 3 and embodiment 4 are subjected to accelerated test, at the same with existing to grind piece " proud smooth" carry out comparative study；
Acceleration study condition：40 DEG C, humidity 75%, 1 month
Relevant substance detecting method is as follows：
Instrument：Shimadzu LC-10A HPLC
Method：Chromatographic column is C18Post, mobile phase A are acetonitrile:10mmol/L potassium phosphate buffers (0.2% triethylamine,
With phosphorus acid for adjusting pH to 3.0)=[45:55]；Mobile phase B is acetonitrile:10mmol/L potassium phosphate buffers (0.2% 3 second
Amine, with phosphorus acid for adjusting pH to 3.0)=[85:15].Gradient elution：0~8min, 100%A, flow velocity 1ml/min, 8~20min,
0%B to 100%B, flow velocity 1.5ml/min, 20.1~25min, 100%B keep 5min, flow velocity 1.5min/ml；Finally return to
To 100%A, flow velocity 1ml/min.Detection wavelength is 240nm.Theoretical cam curve is calculated by olmesartan medoxomil should be not less than 2000.
The different lubricant comparative selection results of table 4
As a result it is (proud that the preparation stability for showing to use inert lubricant to prepare is better than the preparation prepared using alkaline lubricants
Smooth lubricant is magnesium stearate, and Olmesartan acid is the catabolite of olmesartan medoxomil, belongs to one of degradation impurity).
(2) dissolution results
Condition：USP paddle method, 50 revs/min of rotating speed, 900ml PH6.8 phosphate buffers, 37 DEG C, experiment is taken after 30min
Liquid, filtered using the membrane filter that aperture is 0.45 micron, the dissolution rate of olmesartan medoxomil is determined with HPLC methods.
The particle diameter comparative study result (dissolution result) of table 5
As a result show, very crucial effect is played in dissolution of the particle diameter for medicine, and Aomei is prepared using powder direct pressure closing
During husky smooth ester piece, with good result of extraction during 30 microns of the particle diameter ﹤ at 90% cumulative volume.
Claims (3)
1. a kind of olmesartan medoxomil tablet, it is characterized in that, label is made up of olmesartan medoxomil and pharmaceutic adjuvant direct tablet compressing, described
The weight part ratio composition of raw material is 20 parts of olmesartan medoxomil, lactose 100-135 parts, low-substituted hydroxypropyl cellulose in label
10-20 parts, microcrystalline cellulose 30-42 parts, Compritol 888 ATO 2-10 parts；
Particle diameter at the cumulative volume of olmesartan medoxomil 90% is not more than 30 microns；
The preparation technology of the olmesartan medoxomil tablet, step are as follows：
（1）Choose piece core raw material：Label is made up of olmesartan medoxomil and pharmaceutic adjuvant, and pharmaceutic adjuvant includes filler, disintegrant
And lubricant；
（2）Raw material crushes：Olmesartan medoxomil is crushed by air-flow crushing mode, the particle diameter at 90% cumulative volume of control is not
More than 30 microns；
（3）Mixing：The olmesartan medoxomil of crushing is mixed with the filler in pharmaceutic adjuvant, disintegrant, is eventually adding lubricant
Mixing；
（4）Raw material after mixing, according to granule content tabletting；
（5）Coating.
2. a kind of olmesartan medoxomil tablet according to claim 1, it is characterized in that, film coating matrix is selected in the coating
From sweet tablet matrix, water-soluble film coated substrate, intestines film coating matrix, the film coating matrix of sustained release.
3. a kind of olmesartan medoxomil tablet according to claim 2, it is characterized in that, film coating matrix is in the coating
Water-soluble film coated substrate.
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Families Citing this family (6)
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| CN105640913B (en) * | 2016-01-22 | 2018-11-02 | 山东省医学科学院药物研究所 | A kind of olmesartan medoxomil tablet and preparation method thereof |
| KR102051806B1 (en) * | 2018-01-12 | 2019-12-04 | 주식회사 종근당 | Stabilized pharmaceutical formulation comprising Everolimus |
| CN107998097B (en) * | 2018-01-17 | 2018-08-31 | 扬子江药业集团上海海尼药业有限公司 | A kind of tablet and preparation method thereof containing olmesartan medoxomil |
| CN112691084B (en) * | 2019-10-23 | 2023-06-02 | 南京正大天晴制药有限公司 | Pharmaceutical composition and preparation method thereof |
| CN113768894B (en) * | 2021-09-24 | 2023-04-07 | 扬子江药业集团上海海尼药业有限公司 | Olmesartan medoxomil tablet and preparation method and application thereof |
| CN114354824B (en) * | 2022-01-08 | 2024-02-02 | 山东新华鲁抗医药有限公司 | Determination method for dissolution curve of olmesartan medoxomil tablet |
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|---|---|---|---|---|
| CN101679390A (en) * | 2007-03-23 | 2010-03-24 | 第一三共株式会社 | Ground crystal of olmesartan medoxomil |
| CN102028688A (en) * | 2010-12-28 | 2011-04-27 | 北京迈劲医药科技有限公司 | Preparation method of levamlodipine and olmesartan medoxomil tablet |
| CN102327265A (en) * | 2011-07-20 | 2012-01-25 | 海南锦瑞制药股份有限公司 | Amlodipine and olmesartan medoxomil pharmaceutical composition and preparation method thereof |
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2014
- 2014-11-05 CN CN201410618016.9A patent/CN104398483B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101679390A (en) * | 2007-03-23 | 2010-03-24 | 第一三共株式会社 | Ground crystal of olmesartan medoxomil |
| CN102028688A (en) * | 2010-12-28 | 2011-04-27 | 北京迈劲医药科技有限公司 | Preparation method of levamlodipine and olmesartan medoxomil tablet |
| CN102327265A (en) * | 2011-07-20 | 2012-01-25 | 海南锦瑞制药股份有限公司 | Amlodipine and olmesartan medoxomil pharmaceutical composition and preparation method thereof |
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